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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problems Perforation (2001); Spinal Column Injury (2081); Iatrogenic Source (2498)
Event Date 07/17/2017
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight not made available by the journal article authors. Patient age and patient sex not made available the attached journal article or by the authors. The article reports that the age range of 8-76 years and the consisted of male patients in the study. Therefore 42 year old and male were used. Event date is approximated. Date provided is when the journal article was accepted. Citation: sun zx, yuan d, sun yx, zhang zq, wang gh, guo y, wang gq, liu dk, chen p, jing lk, et al. Application of intraoperative o-arm-assisted real-time navigation technique for spinal fixation. Transl. Neurosci. Clin. 2017, 3(3): 135¿146. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Per the journal article, screw penetration may be related to excessive screw lengths and to the implantation angle. Although depth measurements may be performed under navigation, ¿individualizing¿ the screw model is difficult. Screws that are too short may not achieve biological stability, and those that are too long may result in penetrations. In addition, the deviation between the actual spinal position and the navigational image also leads to decreased accuracy, especially in patients requiring multi-segment screw implantations. Hence, when the intraoperative experience differs from expectations, repeated identification and calibration of the navigation system accuracy is necessary. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system. Not returned by customer.
 
Event Description
The attached journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. The study was performed between may 5, 2015 and may 1, 2017 for 36 males and 24 females, the age range was from 8 to 76 years old. The patients were classified into the occipitocervical fusion (32 cases) and thoracic/lumbar/sacral spine fixation (28 cases, including 6 cases of percutaneous pedicle screw) groups. In the occipitocervical fusion group, 6 grade ii screws (the screw penetrated the lateral block or pedicle cortex by >1 mm, but did not need to be adjusted. Also, the patient showed no peripheral tissue injury and the screw was stable) penetrating the lateral block cortex near the vertebral artery, yielding an accuracy of 96. 7%. Among the 84 occipital screws, 3 deviated from the occipital posterior midline position, yielding an accuracy of 96. 4% (81/84). For the thoracic/lumbar/sacral pedicle internal fixation group, 4 grade ii screws that had deviated to the lateral pedicle. Intraoperative imaging system scans were repeated for confirmation. Secondary correction was performed under navigational assistance, yielding a final accuracy of 97. 3%. Screw penetration may be related to excessive screw lengths and to the implantation angle. Although depth measurements may be performed under navigation, ¿individualizing¿ the screw model is difficult. Screws that are too short may not achieve biological stability, and those that are too long may result in penetrations. In addition, the deviation between the actual spinal position and the navigational image also leads to decreased accuracy, especially in patients requiring multi-segment screw implantations. Hence, when the intraoperative experience differs from expectations, repeated identification and calibration of the navigation system accuracy is necessary. The accuracy of screw implantations involving intraoperative imaging system and navigation system did not reach 100%, and the screw skewing may be related to several factors, including the difficulty of positioning screws in the vertebral body so that they are completely consistent with the position scanned by the o-arm, considering the impacts of breathing and implantation force; developmental deformities and variations in the lateral blocks or pedicles, vertebral instability, screw slippage; and surgical equipment operation, screw implantation, and navigation system errors. Conclusion: much of the literature states that the accuracy of navigation-assisted screw fixation is >90%, which is higher than that of traditional screw implantation, improving safety. Intraoperative screw implantation, under intraoperative imaging system and real-time navigation, is highly accurate and has correspondingly good safety. Screw implantation involving intraoperative imaging system' and real time navigation allows observation of the screw angle and depth in real-time, greatly improving implantation accuracy and safety, reducing surgeon and patient exposure to radiation, and shortening the time required for new doctors to learn screw implantation techniques. Finally, these types of navigation techniques will be useful for percutaneous, minimally invasive screw implantations and for endoscopic techniques, which are gradually increasing in frequency. This technique further improves the accuracy of a minimally invasive technology.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
koko tyler
navigation customer quality
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7484563
MDR Text Key107312038
Report Number1723170-2018-01879
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/03/2018 Patient Sequence Number: 1
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